Weight gain associated with intensive therapy in the diabetes control and complications trial. The DCCT Research Group.

Identifiable risks such as increased frequency of hypoglycemia accompany the treatment of insulin-dependent diabetes mellitus (IDDM) with intensive insulin therapy. During yr 1 of the Diabetes Control and Complications Trial (DCCT), weight gain was identified as a sequela of intensive insulin therapy. The DCCT is a multicenter controlled clinical trial designed to determine the long-term effects of two different diabetes treatment regimens on the early vascular and neurologic complications of IDDM. Subjects randomized to the intensive treatment regimen gained significantly more weight (5.1 +/- 4.6 kg) than the standard treatment subjects (2.4 +/- 3.7 kg, P less than .0001) during the 1st yr of therapy. Higher baseline HbA1c levels and greater decrements in HbA1c during intensive therapy were both associated with greater weight gain. In addition, intensively treated subjects with one or more severe hypoglycemic episodes gained more weight than the intensively treated subjects with no severe episodes. There was no relationship between reported caloric intake or exercise level and the weight changes. These data suggest that improved utilization of calories through a decrease in glycosuria and perhaps other mechanisms led to the weight gain in the intensively treated subjects. The results from the 1st yr of experience in the DCCT indicate that weight gain accompanies efforts to lower blood glucose levels with intensive insulin therapy. Because of the potential adverse consequences of undesirable weight gain, including diminished long-term compliance with therapy and an adverse effect on blood pressure and lipid status, efforts to prevent undesirable weight gain in the intensively treated group of the DCCT are being pursued.

RCT Entities:   Population Interventions Outcomes